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510(k) Data Aggregation
(36 days)
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(67 days)
AxSYM® Intact PTH is a Microparticle Enzyme Immunoassay (MEIA) for the in vitro quantitative determination of intact human parathyroid hormone (I PTH) in human serum or plasma on the AxSYM® system. The AxSYM® I PTH assay is intended for use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
AxSYM® I PTH is based on the Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM® I PTH assay uses paired monoclonal and polyclonal antibodies, each reactive with epitopes in the N-terminal portion of intact human PTH (1-84). The polyclonal antibody is biotin labeled. I PTH in the sample serves to bridge the two antibodies.
The provided text does not contain a study that proves the acceptance criteria of the device. Instead, it details the substantial equivalence of the "AxSYM Intact PTH" device to a predicate device, the "DSL-8000 ACTIVE™ Intact PTH IRMA," through method correlation and comparison of various performance characteristics.
Therefore, the following points address the questions based on the information available regarding the substantial equivalence study, rather than a study specifically proving acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in this context are not explicitly stated numerical targets for device performance, but rather the demonstration of "substantial equivalence" to a predicate device. This is primarily shown through method correlation and comparable performance characteristics.
| Feature | Acceptance Criteria (Implied by Predicate Performance / Substantial Equivalence Goal) | Reported AxSYM® I PTH Performance |
|---|---|---|
| Method Correlation | Very high correlation (r value close to 1) between AxSYM® I PTH and predicate device. | r = 0.97 (p < 0.0001) |
| Regression Slope | Slope close to 1.0 (95% CI covering 1.0) | 0.99 (95% CI: 0.95, 1.05) |
| Regression Intercept | Intercept not statistically significant | Intercept not statistically significant (p < 0.35) |
| Precision (Within Run) | Comparable to predicate device. | Level I: 5.9 % CV; Level II: 6.2 % CV; Level III: 6.5 % CV |
| Precision (Inter) | Comparable to predicate device. | Level I: 9.4 % CV; Level II: 8.1 % CV; Level III: 8.8 % CV |
| Linearity | Comparable to predicate device. | 93.8 ± 8.9 % |
| Recovery | Comparable to predicate device. | 95.3 ± 8.9 % |
| Analytical Sensitivity | Equal to or better than predicate device. | ≤ 2.0 pg/mL I PTH |
| Specificity | No detection of human PTH fragments 53-84, 44-68 and 39-84. | No detection of human PTH fragments 53-84, 44-68 and 39-84 |
| Interference | Acceptable interference levels across various substances. | Bilirubin (20 mg/dL): < 10 %; Triglycerides (1500 mg/dL): < 10 %; Total Protein (3 mg/dL): < 10 %; Hemoglobin (1000 mg/dL): < 10 %; Red Blood Cells (0.2 % v/v): < 10 % |
| Dynamic Range | 0 - 2000 pg/mL | 0 - 2000 pg/mL |
| Expected Values | 8 - 57.8 pg/mL or comparable to predicate. | 8 - 57.8 pg/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 120 samples were used for the method correlation study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, given that it's a comparison for regulatory submission, it is likely data collected specifically for this purpose. The samples were "serum and plasma samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not relevant or provided for a chemical assay. The "ground truth" for a quantitative diagnostic assay like this is typically established by measurements from a reference method or a predicate device, as seen here. There are no "experts" in the sense of human adjudicators for establishing ground truth values of PTH in samples.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this involves a comparison to a predicate device, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a quantitative diagnostic immunoassay, not an AI-driven imaging or diagnostic system that involves human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the performance characteristics and method correlation described are for the "AxSYM® Intact PTH" device operating in a standalone capacity (i.e., algorithm/device only). The device provides quantitative results directly from the sample. It is stated that "The I PTH assay is not used as a stand-alone test. Clinical interpretation requires simultaneous measurement of serum calcium levels." This refers to clinical utility, not device performance. The device itself performs its measurement independently.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation, in this context of a substantial equivalence claim, is the performance and measurements obtained from the predicate device, DSL-8000 ACTIVE™ Intact PTH IRMA. The study compared the AxSYM I PTH results to those of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a chemical immunoassay, not an AI/machine learning device that typically requires a "training set" in the computational sense. The device's calibration and internal parameters are set through manufacturing processes and control procedures, not through training on a dataset of clinical cases.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device technology.
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(45 days)
The DSL-10-8500 ACTIVE™ Free 3-hCG Enzyme-Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in serum. This assay is intended for in vitro diagnostic use as an aid in the detection of pregnancy.
The DSL-10-8500 ACTIVE™ Free B-hCG ELISA kit was developed for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in human serum. The DSL ACTIVE® Free B-hCG ELISA is a two-site ELISA assay in which the free ß-hCG to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the inside wall of the microtitration well, the other antibody is conjugated to the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed by washing the wells. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound Free B-hCG is directly proportional to the concentration of the Free ß-hCG present in the sample.
The provided text describes a Substantial Equivalence study for the DSL ACTIVE™ Free β-hCG ELISA kit (DSL-10-8500) against a predicate device, the DSL-8300 Intact-hCG IRMA, for the quantitative determination of Free β-hCG in human serum as an aid in detecting pregnancy.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy thresholds that the new device needed to meet. Instead, it relies on demonstrating substantial equivalence to an existing predicate device (DSL-8300 Intact-hCG IRMA).
The reported performance that serves as the basis for substantial equivalence is primarily through a linear regression analysis and an assessment of physiological profiles in normal individuals.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (DSL-10-8500 ACTIVE™ Free β-hCG ELISA) |
|---|---|
| Strong correlation and agreement with the predicate device (DSL-8300 Intact-hCG IRMA) for pregnant patient samples across varying hCG levels. | Linear regression equation: DSL-10-8500 = 0.007(DSL-8300) - 2.7 |
| Correlation coefficient: r = 0.82 | |
| Statistical significance: p < 0.001 | |
| Expected physiological levels in normal non-pregnant individuals. | 95% of male values were < 1 mIU/mL |
| 95% of female values were < 1 mIU/mL | |
| Conclusion: "The physiological profiles for intact hCG and Free β-hCG remain parallel throughout pregnancy." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 98 pregnant patient samples
- Data Provenance: The document does not explicitly state the country of origin. It mentions "pregnant patient samples" and "serum samples from 20 normal males and 20 non-pregnant females." It is a retrospective evaluation as samples were "collected and assayed" to compare the two methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify a number of experts or their qualifications for establishing ground truth. The "ground truth" for the comparison study appears to be the results obtained from the predicate device, the DSL-8300 Intact-hCG IRMA. For the normal male and non-pregnant female samples, the ground truth is based on the expected physiological range of Free β-hCG in those populations, which is established medical knowledge.
4. Adjudication Method for the Test Set
Not applicable. The study is a comparative method study, not one requiring expert adjudication of subjective findings from the device. The comparison is against the predicate device's quantitative output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is an in-vitro diagnostic (IVD) device for quantitative measurement, not an AI-assisted diagnostic tool that involves human readers interpreting images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study describes the standalone performance of the DSL ACTIVE™ Free β-hCG ELISA kit in comparison to the predicate device. It is a fully automated/semi-automated assay designed to provide a quantitative result without direct human interpretation of complex patterns, but rather an operator running the test and recording the numerical output.
7. The Type of Ground Truth Used
- For the 98 pregnant patient samples, the ground truth was essentially the measurement provided by the predicate device (DSL-8300 Intact-hCG IRMA). The new device's results were compared against this established method.
- For the 20 normal males and 20 non-pregnant females, the ground truth was expected physiological levels for Free β-hCG, which are well-established in medical literature and served to demonstrate the device's ability to correctly identify low/undetectable levels in non-pregnant individuals.
8. The Sample Size for the Training Set
Not explicitly stated. The document describes a "verification" or "validation" study for substantial equivalence rather than explicitly detailing a separate "training set" for the assay's development. IVD assays like ELISA kits are typically developed and optimized using various samples during their R&D phase, but this document focuses on the final validation study.
9. How the Ground Truth for the Training Set Was Established
Not explicitly stated. As above, this document focuses on the validation of the device. The development and optimization ("training") of such an assay would typically involve using samples with known concentrations of hCG (e.g., spiked samples, commutable clinical samples with reference method values) to calibrate and refine the assay's performance characteristics. This information is usually part of the internal development process and not always detailed in an FDA 510(k) summary focused on substantial equivalence.
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(144 days)
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(153 days)
The DSL 10-8400 AFP ELISA assay is intended for the quantitative determination of AFP in human serum. It is intended for in vitro diagnostic use to aid in the management of patients with nonseminomatous testicular cancer.
The DSL-10-8400 ACTIVE™ AFP ELISA is an enzymatically amplified "two-step" sandwichtype immunoassay. In the assay, Standards, Controls and unknown serum samples are incubated in microtitration wells which have been coated with anti-AFP antibody. After incubation and washing, the wells are treated with another anti-AFP detection antibody labelled with the enzyme horseradish peroxidase (HRP). After a second incubation and washing step, the wells are incubated with the substrate tetramethylbenzidine (TMB). An acidic stopping solution is then added and the degree of enzymatic turnover of the substrate is determined by dual wavelength absorbance measurement at 450 and 620 nm.
The absorbance measured is directly proportional to the concentration of AFP present. A set of AFP Standards is used to plot a standard curve of absorbance versus AFP concentration from which the AFP concentrations in the unknowns can be calculated.
Here's an analysis of the DSL 10-8400 ACTIVE™ AFP ELISA Kit's acceptance criteria and the studies performed, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a pass/fail format for each performance characteristic. Instead, it presents the results of various performance studies. For the purpose of this response, I infer "acceptance criteria" from the reported performance, implying that the reported values were deemed acceptable for the device's intended use and for demonstrating substantial equivalence to the predicate device.
| Performance Characteristic | Inferred Acceptance Criterion (Based on reported performance) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Linear regression analysis of comparison data to predicate device should show strong correlation (r ≥ 0.99 for this type of assay). | Y = 1.0(X) + 5.8 with a correlation coefficient of (r) = 0.99 (compared to Abbott IMx AFP Immunoassay) |
| Sensitivity (Limit of Detection) | Low detection limit to identify clinically relevant AFP levels. (No explicit threshold given; 0.7 ng/mL is reported as the theoretical minimum). | 0.7 ng/mL |
| Intra-assay Precision (CV) | Acceptable coefficient of variation (CV) for within-run reproducibility. (Generally, CV < 10% is considered good for many immunoassays, < 5% is excellent). | Sample I (49.3 ng/mL): 6.9% Sample II (163.9 ng/mL): 4.0% Sample III (260.8 ng/mL): 4.9% |
| Inter-assay Precision (CV) | Acceptable coefficient of variation (CV) for day-to-day reproducibility. (Generally, CV < 15% is often acceptable for immunoassays, < 10% is very good). | Sample I (16.7 ng/mL): 10.7% Sample II (99.5 ng/mL): 7.6% Sample III (290.5 ng/mL): 5.6% |
| Recovery | Recovery percentage reasonably close to 100% (e.g., 90-110%). | Range: 94% - 116% |
| Linearity | Recovery percentage reasonably close to 100% across dilutions (e.g., typically 80-120%). | Range: 73% - 114% (Sample I at 1:8 dilution showed 73%, others mostly within 90-114%) |
| Specificity | No significant interference from common related substances or medications. | Prolactin, HLH, HTSH, HCG, Aminophylline, Atropine, Furosemide, Theobromine, Diethylstilbestrol, Megesterol Acetate, 4-Acetamidophenol, Acetylsalicylic Acid, Ascorbic Acid, Caffeine, Ibuprofen, Amethopterine did not interfere. |
| Expected Values (Normal Population) | A high percentage of healthy individuals should have AFP values below clinically significant thresholds (e.g., < 10 ng/mL). | 97.4% of healthy individuals had AFP < 10 ng/mL; 98.0% of healthy males had AFP < 10 ng/mL. |
| Clinical Utility (Nonseminomatous Testicular Cancer Patients) | Demonstrated ability to monitor AFP levels in patients with nonseminomatous testicular cancer, reflecting disease progression, response to treatment, or relapse. | Serial monitoring of 3 patients showed AFP changes correlating with clinical course (relapse, response to chemotherapy). 15 male patients with nonseminomatous testicular cancer showed a distribution of AFP values consistent with expected clinical ranges (e.g., 46.7% > 8.9 - 100 ng/mL, 6.7% > 100 - 400 ng/mL, 13.3% > 400 ng/mL). |
2. Sample Size Used for the Test Set and the Data Provenance
- Substantial Equivalence Study (Method Comparison):
- Sample Size: 73 male human serum samples.
- Data Provenance: Not explicitly stated, but "human serum samples" implies clinical samples. Whether they were retrospective or prospective is not specified. The country of origin is not specified, but the submitter is based in Webster, Texas, USA.
- Performance Characteristics (Analytical Studies - Precision, Recovery, Linearity, Specificity, Sensitivity): These studies typically use a controlled set of samples (e.g., pooled human serum, spiked samples, diluted samples).
- Sample Size:
- Sensitivity: 22 replicates of 0 ng/mL AFP Standard.
- Intra-assay Precision: 14 replicates for each of 3 male human serum samples.
- Inter-assay Precision: 4 replicates for each of 3 human serum samples, done in 2 separate runs each day for 20 days.
- Recovery: 3 male human serum samples, each spiked with 3 different AFP amounts.
- Linearity: 3 male human serum samples, each diluted at multiple factors.
- Data Provenance: "Male human serum samples" is stated for some. These are laboratory-based analytical studies, not clinical patient data. The origin isn't specified beyond "human serum."
- Sample Size:
- Expected Values (Normal Population):
- Sample Size: 199 healthy adult males, 72 healthy adult females.
- Data Provenance: Not explicitly stated, but "a study conducted with apparently normal healthy adults" implies prospective collection for assay validation. Country of origin not specified.
- Longitudinal Study (Clinical Utility):
- Sample Size: 3 patients with diagnosed nonseminomatous testicular cancer were serially monitored. Additionally, 15 male patients with nonseminomatous testicular cancer had their AFP levels determined.
- Data Provenance: Clinical patient data. Retrospective or prospective is not explicitly stated for the 15 patients; for the 3 longitudinal patients, it implies prospective monitoring or use of stored serial samples. Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There is no mention of "experts" being used to establish ground truth in the context of this device's analytical or clinical performance evaluation.
- For the Substantial Equivalence study: The "ground truth" was based on the measurement by the predicate device (Abbott IMx AFP Immunoassay).
- For analytical performance (Precision, Recovery, Linearity, Sensitivity): The "ground truth" or true value is based on the known concentrations of standards, spiked amounts, or calculated values from dilutions. These are intrinsic to the assay's design and laboratory experimentation.
- For Expected Values and Longitudinal Studies: The "ground truth" for patient diagnosis (nonseminomatous testicular cancer) would have been established by standard clinical diagnostic procedures (e.g., histology, imaging, clinical presentation), which would implicitly involve expert medical practitioners, but the document does not detail this. The AFP values themselves are the direct measurements from the device in these studies.
4. Adjudication Method (for the test set)
No adjudication method is described. For most in vitro diagnostic (IVD) assays, particularly quantitative ones like ELISA, adjudication by experts for ground truth is not typically part of the analytical validation or method comparison. The measured values from the device or the predicate device are directly compared or analyzed. Clinical outcomes (disease diagnosis, response to treatment) form the "ground truth" for clinical utility, which is established through standard medical practice rather than an active adjudication process for the purpose of validating the assay.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret images with and without AI assistance. The DSL 10-8400 ACTIVE™ AFP ELISA Kit is an in vitro diagnostic assay that provides a quantitative numerical result, and therefore, an MRMC study is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies presented are primarily standalone performance assessments of the DSL 10-8400 ACTIVE™ AFP ELISA Kit. The device provides a quantitative measurement of AFP; it doesn't involve a "human-in-the-loop" for interpretation in the same way an imaging AI might. The clinical utility studies demonstrate how the results from the device aid in patient management, but the performance characteristics (sensitivity, precision, recovery, etc.) are evaluating the device itself, separate from human interpretation or modification of its direct output.
7. The Type of Ground Truth Used
- Substantial Equivalence Study: The predicate device's (Abbott IMx AFP Immunoassay) results served as the reference or "ground truth" for comparison.
- Analytical Performance Studies (Sensitivity, Precision, Recovery, Linearity, Specificity): The "ground truth" was based on known concentrations of standards, known amounts of spiked AFP, or expected values from dilutions.
- Expected Values Study: The "ground truth" for these samples was based on the clinical status of the individuals (apparently normal healthy adults).
- Longitudinal / Clinical Utility Studies: The "ground truth" for these patients was established through clinical diagnosis of nonseminomatous testicular cancer and monitoring of their clinical course and response to treatment, presumably via established medical diagnostic and monitoring protocols (e.g., biopsy/histology, imaging, other markers).
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. This is an ELISA kit, which is a biochemical assay. The "training" of such a device would involve optimizing the assay reagents and protocols during development. The various performance studies mentioned serve as validation of the developed assay.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/machine learning device, the concept of a "training set" and its "ground truth" in the AI sense does not apply. The development of the assay (akin to "training" in a broader sense) would involve extensive experimentation with known AFP concentrations in various matrices to establish optimal antibody concentrations, incubation times, substrate reactions, and standard curve parameters. The "ground truth" for such development would be the precisely known concentrations of AFP standards and controls.
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(165 days)
The DSL-10-42100 C-Reactive Protein (CRP) Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of CRP in human serum. The measurement of CRP aids in the evaluation of the amount of injury to body tissues.
The DSL C-Reactive Protein (CRP) ELISA kit was developed for the quantitative measurement of CRP in human serum. The ELISA format is a capture assay. Rabbit anti-human polyclonal antibody against CRP is immobilized to the inner surface of the microtiter plate wells. CRP in the standards or serum samples is "sandwiched" between this antibody and the anti-CRP rabbit polyclonal antibody conjugated to horseradish peroxidase enzyme.
The provided text describes a 510(k) submission for the DSL 10-42100 C-Reactive Protein ELISA kit, which aims to demonstrate substantial equivalence to a legally marketed predicate device. While it details the device, its intended use, and a comparative study, it does not explicitly state specific acceptance criteria in terms of numerical thresholds for performance metrics. Instead, the study's aim was to establish "substantial equivalence" based on a correlation coefficient.
Based on the provided information, here's what can be extracted and inferred regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Correlation Coefficient (r) | Not explicitly stated as a numerical threshold, but implicitly, a strong correlation indicating substantial equivalence. | r = 0.98 |
| Linear Regression Equation | Not explicitly stated as a numerical threshold, but implicitly, a regression equation close to Y=X suggests close agreement. | Y = 0.827x + 349.44 |
Note: The FDA's determination of "substantial equivalence" is the overarching acceptance criterion addressed by the study. The study's results (high correlation coefficient) were deemed sufficient by the FDA for this determination.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
n = 79patient samples. - Data Provenance:
- Country of Origin: Not explicitly stated, but given the submitter's address (Webster, Texas, USA) and the FDA's regulatory context, it's highly probable the samples were collected in the USA.
- Retrospective or Prospective: Not explicitly stated. The phrasing "patient samples (n=79) were collected and assayed simultaneously by both methods" suggests a prospective collection for the purpose of this comparison, but it could also be a mix of newly collected and existing archived samples. Without more detail, it's difficult to definitively categorize. The samples were chosen "from male and female subjects with low, medium and high serum CRP levels," implying a controlled selection rather than purely retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study compares the new device (DSL CRP ELISA) against a predicate device (Hemagen Diagnostics, Inc. CRP 150 Kit), not against a human expert's interpretation or a "ground truth" established by experts in the typical sense of diagnostic imaging or clinical assessment. The ground truth, in this context, is effectively the measurement obtained by the predicate device.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are usually relevant when multiple human reviewers independently assess data and their discrepancies need to be resolved to establish a consensus ground truth. In this study, measurements are quantitative and compared directly between two devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with and without AI assistance. The described study is a direct comparison of a new laboratory diagnostic device with a predicate laboratory diagnostic device, without human readers in the loop for interpretation in the specified context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The study directly compared the measurements of the new DSL CRP ELISA kit (the "algorithm/device") against the predicate Hemagen Diagnostics CRP 150 Kit, without human interpretation as part of the primary output. The DSL 10-42100 C-Reactive Protein ELISA Kit is the standalone device.
7. The Type of Ground Truth Used
The "ground truth" for this study was effectively the measurements obtained from the legally marketed predicate device, the Hemagen Diagnostics, Inc. CRP 150 Kit. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the predicate device's performance is assumed to be acceptable.
8. The Sample Size for the Training Set
This information is not provided in the document. The provided text describes a 510(k) submission, which focuses on validation, not the development or training of the device. ELISA kits are typically based on well-established biochemical principles and do not involve "training sets" in the same way machine learning algorithms do.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. As mentioned above, ELISA kits do not typically have a "training set" in the machine learning sense. The assay's design and parameters would have been established through a standard biochemical development process, relying on known chemical reactions and established methodologies for measuring CRP.
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(339 days)
The DSL-9700 Active™ PSA Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.
The DSL 10-9700 PSA ELISA kit was developed for the quantitative measurement of Total PSA in human serum. The ELISA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the microtiter plate wells, the other antibody is conjugated the the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwich" complex. Unbound materials are removed by decanting and washing the microtiter plate. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.
The provided text describes the DSL 10-9700 PSA ELISA Kit and its substantial equivalence study. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for the new device itself. Instead, it demonstrates substantial equivalence to a predicate device. The performance criterion implicitly accepted is a strong linear correlation and agreement with the predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (DSL 10-9700 PSA ELISA) |
|---|---|---|
| Correlation with Predicate Device (DPC IMMULITE PSA) | Strong linear correlation | Linear regression: Y = 1.11[DPC IMMULITE] + 0.77 |
| High correlation coefficient | Correlation coefficient (r) = 0.96 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 193 human serum samples.
- Data Provenance: The document states "human serum samples (n = 193) were collected." It does not specify the country of origin of the data. The samples were chosen "based on expected PSA levels so that samples with low, intermediate and high levels would be evaluated."
- Retrospective or Prospective: Not explicitly stated, but the description "samples were collected and assayed using both methods" suggests a prospective collection of samples for the purpose of the comparison study, or at least a concurrent analysis of an already collected sample bank. It does not definitively state if these were newly drawn specifically for this study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study establishes equivalence to a predicate device, not against an independent 'ground truth' established by experts interpreting clinical outcomes or pathology. The "ground truth" in this context is the results obtained from the predicate DPC IMMULITE PSA assay.
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication process described, as the comparison was between two assays, not expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This is an in vitro diagnostic device for measuring a biomarker, not an imaging or diagnostic device requiring human interpretation of results in the traditional sense of an MRMC study. The comparison is between two laboratory assays.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence. The DSL 10-9700 PSA ELISA kit is a standalone assay (a laboratory test) that provides a quantitative measurement. Its performance is evaluated intrinsically through its ability to quantify PSA and extrinsically by comparing its results to a legally marketed predicate device. There is no "human-in-the-loop" decision-making component for the device itself; humans operate the device and interpret its quantitative output.
7. The Type of Ground Truth Used
The "ground truth" for the comparative effectiveness study was the results obtained from the DPC IMMULITE PSA assay, which is itself a legally marketed and presumably validated assay for Total PSA. The study aimed to show that the new device's measurements align closely with the predicate device's measurements.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or AI development. The ELISA kit is a biochemical assay. The 193 samples were used for the equivalence comparison study, which can be considered analogous to a "test set" for validating performance against a standard.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an algorithm or AI in this context, this question is not applicable. The device is a laboratory assay.
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(339 days)
The DSL-9700 Active™ PSA Immunoradiometric Assay (IRMA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.
The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the coated tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwich" complex. Unbound materials are removed by decanting and washing the tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.
The provided text describes the DSL 9700 PSA IRMA kit, an immunoradiometric assay for the quantitative measurement of Total PSA in human serum. This device is intended to aid in the management (monitoring the recurrence of prostate cancer) of prostate cancer patients.
Here's an analysis of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (DPC IMMULITE PSA assay) must be demonstrated. | Equivalence Demonstrated: Linear regression analysis of 286 human serum samples tested on both the DSL 9700 PSA IRMA and the DPC IMMULITE PSA assay resulted in the equation Y = 1.25(DPC IMMULITE) + 0.33 with a correlation coefficient (r) = 0.97. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: 286 human serum samples.
- Data Provenance: The document does not explicitly state the country of origin. It can be inferred that these were human serum samples collected for this specific validation, but it doesn't specify if they were retrospective or prospective. Given the context of a 510(k) submission, it's likely they were carefully selected for the purpose of demonstrating equivalence retrospectively.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study focuses on comparing the new device against a predicate device, not on establishing a ground truth via expert review of patient cases.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The study compares two assays directly using quantitative measurements, not through an adjudication process of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The DSL 9700 PSA IRMA kit is an in-vitro diagnostic device (an assay), not an AI-powered diagnostic imaging or interpretation system that would involve human readers or AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone study was performed. The DSL 9700 PSA IRMA kit is a laboratory assay that provides a quantitative measurement. The performance (measurement of PSA levels) is determined by the assay kit itself, without human interpretation of images or complex decision-making based on algorithm output. The study described is a direct comparison of the numerical outputs of the DSL 9700 PSA IRMA kit and the DPC IMMULITE PSA assay.
7. The Type of Ground Truth Used
The "ground truth" in this context is the quantitative measurement provided by the predicate device, the DPC IMMULITE PSA assay. The goal was to establish substantial equivalence to this already legally marketed device, meaning its measurements are accepted as the standard for comparison. The samples were chosen across a range of expected PSA levels (low, intermediate, high), implying that the actual PSA level in each sample, as determined by the predicate, was the reference point.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. For this type of in-vitro diagnostic device, the "development" or "calibration" might involve internal runs during product development. The provided sample size (n=286) refers to the set used for demonstrating substantial equivalence to the predicate device, which would typically be considered a validation or test set in the context of a regulatory submission.
9. How the Ground Truth for the Training Set Was Established
Given that this is an In-Vitro Diagnostic (IVD) assay and not an AI or imaging device, the concept of "ground truth for a training set" as it relates to expert annotations for AI is not applicable. The development of such assays involves establishing analytical performance characteristics (e.g., sensitivity, specificity, accuracy, precision) against known standards or reference methods. The "ground truth" for calibrating or developing the DSL 9700 PSA IRMA assay would likely have been established through:
- Reference materials with certified PSA concentrations.
- Cross-validation with established, highly accurate laboratory methods or other well-characterized PSA assays.
The document does not detail these specific developmental steps, as the summary focuses on the comparative study for regulatory clearance.
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The DSL ACTIVE™ Renin Coated Tube IRMA assay is intended for the quantitative determination of active renin in human serum or plasma. This assay is intended for in vitro diagnostic use. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.
The DSL 25100 ACTIVE™ Renin Coated Tube IRMA Kit was developed for the quantitative measurement of active renin in human serum or plasma. This Coated Tube IRMA format is a capture assay. Anti-human renin mouse monoclonal antibody to renin is immobilized to the surface of the coated bead. Renin in the standards or samples is "sandwiched" between this monoclonal antibody and the anti-human Renin mouse monoclonal antibody radiolabeled for detection with I-125.
The DSL ACTIVE™ Renin Coated Tube IRMA kit was evaluated for its substantial equivalence to the Nichols Diagnostics ACTIVE Renin IRMA. The study involved comparing the results from both assays on patient samples to establish this equivalence.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence: Demonstrated through linear regression analysis and correlation coefficient comparing against the predicate device. | Linear Regression Equation: Y = 0.94(X) - 5.3 |
| Correlation Coefficient (r): 0.94 |
Note: The document implicitly defines substantial equivalence based on a high correlation and a linear relationship between the new device and the predicate device's measurements. Specific thresholds for the slope, intercept, or correlation coefficient for "acceptance" are not explicitly stated as numerical criteria, but the reported values were deemed sufficient for substantial equivalence by the FDA.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 53 patient samples
- Data Provenance: The document states "patient samples were collected." No specific country of origin is mentioned, but the submitting company is based in Webster, Texas, USA. The data is retrospective in the sense that samples were collected and then assayed simultaneously by both methods, rather than being collected solely for future study. The samples were chosen based on expected Renin levels (low, intermediate, and high) to ensure a representative range.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There were no independent experts used to establish a new ground truth. Instead, the Nichols Diagnostics ACTIVE Renin IRMA served as the reference method, or "ground truth," for comparison. The performance of this predicate device itself would have been established through prior studies.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) was used for the test set. The comparison was direct between the new device and the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted, as this device is an in vitro diagnostic (IVD) kit for quantitative measurement and does not involve human reader interpretation in the same way imaging devices might. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This study is a standalone performance evaluation of the device (the kit itself), comparing its results directly to a predicate device. There is no "human-in-the-loop" aspect to the device's function or the comparative study described.
7. Type of Ground Truth Used
The "ground truth" for the test set was the results obtained from the Nichols Diagnostics ACTIVE Renin IRMA, which served as the predicate device and the reference standard for comparison. This is a form of comparative ground truth against an established and legally marketed device.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its size. The 53 patient samples were used for the comparative clinical study to demonstrate substantial equivalence, which is typically a validation or test set in the context of device approval. If a training phase was involved in the development of the DSL ACTIVE™ Renin Coated Tube IRMA kit, that information is not provided in this summary.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated training set is not explicitly mentioned, the method for establishing its ground truth is also not provided. For IVDs like this, the "training" (development and optimization) often involves internal testing against characterized samples or reference materials, which would have their values established through validated reference methods or inter-laboratory comparisons, but these details are not part of this 510(k) summary.
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